GLS-5310 Vaccine for the Prevention of SARS-CoV-2 (COVID-19)

SARS-CoV-2 Clinical Trial

Official title:

Multicenter, Randomized, Combined Phase I Dose-escalation and Phase IIa Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Immunogenicity of GLS-5310 DNA Vaccine, Administered Intradermally Against SARS-CoV-2 in Healthy Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04673149
• Other study ID #: CoV2-001
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: December 23, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2022
• Source: GeneOne Life Science, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial will evaluate the safety, tolerability and immunogenicity of GLS-5310 DNA vaccine against SARS-CoV-2(COVID-19) in healthy volunteers.

Description:

This Phase I / IIa study will assess the safety, tolerability, and immunogenicity of GLS-5310 DNA vaccine.

The Phase I portion of this study is an open-label, dose escalation study to assess two dose levels of GLS-5310 DNA vaccine (0.6 and 1.2 mg) as part of two vaccination regimens (0-8 weeks and 0-12 weeks).

The Phase IIa portion of this study is designed as a randomized, double-blind, placebo-controlled study with only a single active study drug arm. Subjects will be randomized to receive either placebo or GLS-5310 vaccine in a 1:2 ratio.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 183
• Est. completion date: December 31, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age 19 to 65 years of age (Phase I will be restricted to an upper age limit of 50 years of age)

2. Able to provide informed consent

3. Able and willing to comply with study procedures

4. For women of childbearing potential, able and willing to use an approved form of pregnancy prevention through to 4 weeks post boost vaccination

Exclusion Criteria:

1. Current or planned pregnancy through to 4 weeks post-boost vaccination for women of childbearing potential

2. Currently breastfeeding

3. Current or past participation in a coronavirus (MERS-CoV, SARS-CoV-2) vaccine study

4. Administration of an investigational agent within 6 months of the 1st dose

5. Administration of a vaccine within 4 weeks prior to the 1st dose

6. Administration of immune globulin within 16 weeks of enrollment

7. Administration of an anti-TNFa inhibitor such as infliximab, adalimumab, etanercept, or anti-CD20 monoclonal antibody rituximab within 24 weeks prior to enrollment

8. Current daily treatment of systemic corticosteroids of 20 mg of prednisone or greater, dexamethasone of 3 mg or greater; or the equivalent dose of other systemic corticosteroids

9. Administration of any Immunosuppressive Drug or Immunomodulator within 3 months of the first dose

10. History of bone marrow transplantation

11. Current or planned chemotherapy treatment for hematologic or solid tumor during study period or treatment during the 5 years prior to enrollment

12. Respiratory disease (ex. Asthma, Chronic obstructive lung disease)

13. Cardiovascular disease (ex. myocardial ischemia, congestive heart failure, cardiomyopathy, clinically significant arrhythmia)

14. Hypertension (Systolic pressure >150mmHg or Diastolic pressure >95mmHg)

15. Confirmed Diabetes

16. Severe allergic reaction or anaphylactic reaction after vaccination in the past

17. Immunosuppresion including immunodeficiency disease or family history

18. Positive of serum test at screening (Hepatitis B, Hepatitis A, HIV, Hepatitis C)

19. Baseline screening lab(s) with Non Clinical Significant abnormality

20. Serious adverse reaction to a drug containing Investigational Product (GLS-5310) or other ingredients of the same categories or to a vaccine or antibiotic, nonsteroidal anti-inflammatory disease control, etc. or an allergic history

21. History of hypersensitivity to vaccination such as Guillain-Barre syndrome

22. History of PCR-confirmed infection with SARS-CoV-2 at screening

23. Subjects who have been contact with COVID-19 infections in the past prior to administration, have been classified as COVID-19 confirmed patients, medical patients or patients with symptoms or have been identified with SARS and MERS infection history in the past

24. 37.5 degrees, cough, difficulty breathing, chills, muscle aches, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to administration

25. Healthcare workers participating in the medical examination of patients infected with COVID-19

26. Not willing to allow storage and future use of samples for SARS-CoV-2 related research

27. Prisoner or subjects who are compulsorily detained for treatment of a psychiatric illness

28. Any illness or condition that, in the opinion of the investigator, may affect the safety of the subject or the evaluation of a study endpoint

Related Conditions & MeSH terms

• SARS-CoV-2

Intervention

Biological:
• GLS-5310
GLS-5310 DNA plasmid vaccine
• Placebo
Placebo

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
GeneOne Life Science, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Determine IgG antibody responses after a single dose of vaccine related to treatment arm	Endpoint titer of binding antibody in serum at each timepoint	Through 1 year post vaccination
Other	Measure survival rate of animals administered immune serum from vaccinated individuals and later challenged with SARS-CoV-2.	Survival rate	Through 1 year post vaccination
Other	Persistence of immune responses following vaccination with GLS-5310	Endpoint titer of binding antibody in serum at each timepoint; Plaque-reduction neutralizing titer in serum at each timepoint; T-cell response of antigen-specific interferon - gamma (IFN-?) secretion in PBMC at each timepoint	Through 1 year post vaccination
Other	Determine the extent of immune boosting for participants who are seropositive at baseline following vaccination with GLS-5310	Change from baseline in binding antibody titers; Change from baseline in T-cell response of antigen-specific interferon - gamma (IFN-?); Change from baseline in plaque-reduction neutralizing titer(PRNT) in serum	Through 1 year post vaccination
Other	Measure viral load in organs, including blood, of animals administered immune serum from vaccinated individuals and later challenged with SARS-CoV-2.	viral load measurement of blood and major organs	Through 1 year post vaccination
Other	Perform histologic examination of organs of animals administered immune serum from vaccinated individuals and later challenged with SARS-CoV-2.	pathological examination of organs	Through 1 year post vaccination
Primary	Incidence of adverse events	solicited/unsolicited local and systemic AEs after vaccination	Through 48 weeks post vaccination
Primary	Geometric mean titer (GMT) of antigen-specific binding antibody titers	Endpoint titer of binding antibody in serum	Through 48 weeks post vaccination
Secondary	Evaluation of positive response rate of T cell responses induced by GLS-5310 DNA vaccine	T-cell response of antigen-specific interferon - gamma (IFN-?) secretion in PBMC at each timepoint	Through 48 weeks post vaccination
Secondary	Geometric mean titer (GMT) of neutralizing antibody titers	Plaque-reduction neutralizing titer(PRNT) in serum at each timepoint	Through 48 weeks post vaccination